NEWS AND VIEWS FROM THE PHARMACEUTICAL FINE CHEMICAL AND CUSTOM MANUFACTURING SECTOR

Wednesday, 15 September 2010

Grace to acquire Synthetech

WR Grace is to acquire Synthetech for $19.2 million, less Synthetech’s unpaid debt and transaction costs at closing, and subject to a minimum cash balance of $600,000. The acquisition will expand Grace's pharmaceutical offering by adding expertise in chiral and peptide intermediate synthesis in addition to capacity for the manufacture of specialty single-site and polypropylene catalysts used to produce plastics.
Baltimore Sun

Thursday, 9 September 2010

Diosynth RTP will manufacture the API for Nabi Biopharmaceuticals' NicVAX anti-smoking vaccine

Nabi Biopharmaceuticals

Lonza signs manufacturing deal with GSK

GlaxoSmithKline has selected Lonza to produce early stage monoclonal antibodies from its biopharmaceutical pipeline. Initially Lonza will manufacture clinical trial batches of five compounds currently in Phase I and II. In addition GSK will also have flexible access to Lonza's capabilities for future demand dependent upon progression of molecules through late stage development and commercial launch.
Reuters

Socma welcomes R&D Tax Credit decision

Socma has welcomed the decision by US President Barack Obama to to expand and simplify the R&E Tax Credit and to make it permanent to help encourage future productivity and growth. Socma has advocated for this for a numb roof years, said Socma President and CEO Lawrence Sloan welcoming the plan.
Socma

Tuesday, 31 August 2010

Jubilant signs $33m CRAMS deal

Jubilant Organosys has signed its second major CRAMS deal in a week. The company has signed a $33m, long-term contract with a US life sciences company. R Sankaraiah, Jubilant's Executive Director of Finance, said the company would book $250m orders in this year and $250m-$300m in the next three-four years.
Money Control

Lonza acquires Vivante

Lonza has purchased Vivante GMP Solutions to give it a foothold in the viral-based manufacturing market. Lonza said the acquisition advances its strategy to broaden its biologics custom service offering for the growing viral vaccine and gene therapy markets. Vivante, which is based in Houston, TX, produces GMP viral-based therapeutics.
Lonza

Ricerca Biosciences has successful completion of the HPLC prep purification of an API under cGMP conditions

Ricerca

CMC adds disposable manufacturing

CMC Biologics has completed the addition of a state-of-the-art biopharmaceutical disposable manufacturing facility at its Seattle, WA site. CMC Biologics has partnered with Hyclone to supply the multi-purpose, single-use facility with processing equipment, including a 100L and two 500L single-use bioreactors and disposable mixers.
Genetic Engineering and Biotechnology News

Saltigo will increase prices for its 1,2,4 Triazol product range by 10% from 1 September 2010

Saltigo

Contract manufacturing revenues for Ark Therapeutics in H1 totalled £0.406m of which £0.338m was from one customer

Ark Therapeutics

Cedarlane will market and distribute Phenex's high value reagent proteins in Canada and the US

San Diego Union-Tribune

Tuesday, 24 August 2010

Jubilant signs CRAMS deal

Jubilant Organosys has signed a $51m, four-year research and manufacturing deal with an unnamed US company. The company is in discussions to expand the contract, which could be extended by a further five years. R Sankaraiah, Jubilant's Executive Director of Finance, said the deal takes Jubilant;s CRAMS order book over $1bn.
Money Control

Wednesday, 18 August 2010

Aesica invests in high containment

Aesica is investing £3m in a new high containment facility at its Queensborough, UK, site. The facility, which is due to be completed by May 2011, will enable Aesica to manufacture potent drugs typically classed as Safebridge category 3 and significantly extend its current capabilities in the formulation and packaging of liquid and solid dosage forms. In addition, the new facility will also include security measures that will ensure it can manufacture Schedule II controlled drugs such as opiates.
The Northern Echo

SAFC has extended its agreement to distribute Novozymes Biopharma's LONG R3 growth factor for industrial cell culture applications

Sigma Aldrich

Tuesday, 17 August 2010

EMA and FDA plan joint inspections

The European Medicines Agency (EMA) and the US FDA are seeking potential candidate companies for a joint GMP inspection pilot programme for manufacturers of medicinal products. The agencies are hoping to see whether greater international collaboration can help to distribute inspection capacity allowing more manufacturing sites to be monitored and reducing unnecessary duplication.
EMA

AMRI is the winner of the inaugural Pfizer Route Design Innovation Award for innovative ideas in process chemistry and large scale API production

Albany Times Union

Monday, 16 August 2010

Carbogen hinders Dishman

Dishman's Q1 turnover fell 12% to $43.2m. The company's CFO, VVS Murthy, put the fall down to reduced revenues at its Carbogen subsidiary. However, he expects Carbogen to see an overall 10% rise in sales over the full year.
Money Control

Synthetech's Q1 revenues fell 56% to $2m and the company reported a loss of $727,000 compared to a $1m profit in 2009

San Francisco Business Times

Thursday, 5 August 2010

Revenues at Codexis rose 28% to $24.5m in Q2 compared to 2009, with product revenues rising 102% to $8.5m

Codexis

Senator introduces safe drug manufacturing bill

US Senator, Michael Bennet, has introduced a bill, the US Drug Safety and Accountability Act of 2010, which aims to strengthen manufacturing quality standards, enhance the US FDA’s ability to track foreign manufacturing sites, and increase the authority of FDA to make drug product recalls. Socma welcomed the introduction of the bill and thanked the Senator for "introducing this common sense legislation which will strengthen the FDA and increase public health and safety by providing additional quality controls on drugs and their ingredients."
Senator Bennet
Socma

US consumers don't trust safety of foreign manufactured drugs

A survey conducted by the Pew Prescription Project has shown that US consumers do not trust the safety and freedom from contamination of drugs manufactured overseas. 78% of those polled trusted US made drugs, but only 6% trusted those made in China, 8% India and 30% Ireland. Swiss manufactured products were trusted by 47% and Canada made 60%.
Pharma Times

Lonza and Roslin Cells will combine their capabilities to develop customised cell culture media and processes to produce of pluripotent stem cells

Genetic Engineering News

Ampac revenues rise in Q3

Ampac's fine chemicals businesses reported revenues of $20m in its Q3 ended June, compared to $15.6m in 2009, reflecting an increase in revenues from products in development. However, the operating loss for the quarter grew from $0.8m to $2.5m as a result of higher than anticipated costs associated with validating a process change for a core product and general manufacturing inefficiencies.
Ampac

AMRI plans to double capacity at its Singapore facility

Outsourcing Pharma

Wednesday, 4 August 2010

AMRI revenues rise in Q2

Q2 revenues for AMRI's contract division rose 5% to $40.7m. The small scale manufacturing business revenues rose 1% to $8.2m and the large scale manufacturing revenues rose 10% to $21m.
AMRI

Pfenex awarded anthrax tech contract

The US Department of Health and Human Services has awarded Pfenex $18.8m contract to support the development of a robust Pfenex Expression Technology based production strain and process for the production of bulk recombinant protective antigen (rPA) from anthrax. Pursuant to the contract, Pfenex will identify high producing expression strains capable of producing high titers of stable rPA and then develop commercial cGMP manufacturing process.
Xconomy

Cambrex sales fall

Q2 sales at Cambrex fell 4% to $57.4 million. Cambrex said the decrease is primarily due to lower demand for certain larger products including the effects of a supply chain disruption at a customer's facility, lower pricing on generic APIs and a renegotiated contract extension for certain drug delivery products resulting in lower pricing. However the company saw higher sales volume of controlled substances and generic APIs.
Outsourcing Pharma

Tuesday, 3 August 2010

DSM Pharma sales rise

DSM's Pharmaceutical Products business unit reported 5% sales growth in Q2 2010 compared to 2009. However, profit fell as a result of a challenging business environment and unfavourable product mix. DSM said the drop in results was somewhat compensated by the development of the US dollar.
DSM

Siegfried has outsourced maintenance and utility services at its Zofingen, Switzerland, facility

Siegfried

Aesica raises £20m

Lloyds TSB Corporate Markets has provided £20m to Aesica Pharmaceuticals to support its continuing expansion through organic growth and acquisitions.
Pharmacy Business

Monday, 2 August 2010

SynCo to manufacture second product for Versartis

SynCo Bio Partners has extended its collaboration with Versartis, Inc. SynCo will scale-up a second manufacturing process on behalf of Versartis and provide fill and finish services for the manufacture, testing and release of formulated Drug Product vials.
Pharmaceutical Business Review

Sales at Hovione for the fiscal year ended March 31st 2010 rose 15% over 2009 to $144m

In-pharma Technologist

Aptuit partners with Siena

Siena Biotech has acquired a minority stake in Aptuit’s operations in Verona, Italy. In return, Aptuit will become the provider of choice for Siena’s development pipeline of compounds, focused in three key therapeutic areas, including Alzheimer’s disease, Huntington’s disease and oncology.
Mass High Tech

Fine chems sales rise at Albemarle

Sales for Albemarle's Fine Chemistry business rose 36% to $141.2m in Q2. The company said this was the result of increased volumes in both our performance chemicals and fine chemistry services businesses, and partly offset by product mix.
Business Week

Wednesday, 28 July 2010

CMC Biologics will manufacture ProtAffin's lead product for the treatment of chronic obstructive pulmonary disease at its Copenhagen, Denmark facility

Pharmaceutical Business Review

Novasep is working with Cerenis to further optimise the manufacturing process for its HDL mimetic following €10.7m funding from the French Govt

Novasep

The UK's medicines regulator, the MHRA, has clarified its guidance for API manufacturing site authorisation

MHRA

Daiichi Sankyo will use BioWa and Lonza's Potelligent CHOKS1V cell line for development and production of recombinant therapeutic antibodies

Genetic Engineering News

Signs of recovery for SAFC

Sales for Sigma-Aldrich's SAFC business unit showed double-digit growth in Q2, rising to $157m. The company said that several of the SAFC markets that were depressed in 2009 are beginning to show good signs of recovery. Jai Nagarkatti, Sigma-Aldich Chairman, President and Chief Executive Officer, said "I think SAFC pharma business still is not recovered to the extent that we would like to see it recover" and Rakesh Sachdev, Senior Vice President and Chief Financial Officer, added that "we expect the SAFC pharma business to improve in the second half".
Seeking Alpha

Thursday, 22 July 2010

Custom manufacturing sales hit Lonza

Profits for H1 2010 at Lonza were CHF135m up 14% from CHF118m in 2009, however sales fell 2% to CHF1301m. In the custom manufacturing division sales fell almost 7% to CHF658m due to anticipated low capacity utilisation in Portsmouth and Hopkinton in Q1 2010. In the chemical manufacturing business Lonza continued to be affected by customers’ efforts to optimise their overall cost base and net working capital. The company successfully implemented of a number of operational excellence programs which have increased the flexibility and throughput of most of its chemical manufacturing assets and will meet the new customer requirements. Lonza's biological manufacturing business continued to operate at high batch success rates, above the industry average and multiple new products and production campaigns had a positive impact on its mid- and large-scale asset utilisation.
Reuters

Tuesday, 20 July 2010

Reaxa will lead a five-company consortium with a £718,000 Technology Strategy Board grant simpler, cleaner, lower-cost manufacturing processes

Reaxa

Angel posts H1 profit

Angel Biotechnology has reported a profit of £106,000 in the first six months of 2010. The company said it has secured business for the rest of the year and expects to post a profit for the full year.
The Herald

Apicore's Somerset, NJ, API manufacturing facility has successfully completed a US FDA inspection

BusinessWire

Eden to develop Itero biosimilar

Eden Biodesign will provide process development for Itero Biopharmaceutical’s biosimilar recombinant follicle stimulating hormone. The product has been licenced by Eden's parent company, Watson Pharmaceuticals.
San Francisco Business Journal

Thursday, 8 July 2010

Jubilant to focus on life sciences

Jubilant Organosys is to spin off its agri-chem and performance polymer business units into a separate business Jubilant Industries and rename itself Jubilant Life Sciences.
Reuters

Tuesday, 6 July 2010

Socma’s Bulk Pharmaceuticals Task Force (BPTF) has introduced a standardised quality drug agreement for CMOs and their customers

Socma

Girindus will validate a manufacturing process for an oligonucleotide product currently in Phase III clinical trials

Girindus

Aptuit acquires GlaxoSmithKline's medicines research centre in verona, Italy

PM Live

BASF merges Swiss fine chems units

BASF has merged its Evionnaz, Switzerland- based businesses BASF Orgamol Pharma Solutions and BASF Fine Chemicals Switzerland into a single organisation, BASF Pharma (Evionnaz). BASF said the merger reduces complexity at its site and simplifies processes.
In-Pharma Technologist

Thursday, 1 July 2010

Aesica acquires R5, plans more

Aesica has acquired R5, which develops and manufactures new medicines and clinical trial materials, for an undisclosed sum. Chief Executive, Robert Hardy, said the company is currently considering a number of additional takeover targets overseas as part of its expansion plans including a formulation manufacturer in the US and Europe.
North East Business

CPhI to be held in Frankfurt in 2011

The annual trade show will take place on 25-27 October 2011 at the Messe, Frankfurt.
PR Newswire

Synthetech has hired a financial adviser to explore alternatives including selling the company

Portland Business Journal

Saltigo's Leverkusen site has successfully completed an FDA audit

Contract Pharma

DCGI to inspect China plants

India's drug regulator, the Drug Controller General of India (DCGI), is planning to start inspecting manufacturers in China supplying intermediates and APIs to Indian manufacturers.
DWS Pillscribe

Rumour: Dishman to sign manufacturing deals worth $40m with Abbott and Merck

Economic Times

Wednesday, 23 June 2010

ICICI seeks buyer for RFCL

ICICI Ventures is looking to sell RFCL, which includes fine chemicals and in vitro diagnostics businesses. ICICI is believed to be looking to raise $87m.
Business Standard

Borregaard closes Italian plant

Borregaard Synthesis is closing its production plant in Ravenna, Italy, as a result of challenging market conditions which it does not see changing in the near future. 40 employees will be affected.
Borregaard

Tuesday, 22 June 2010

Ricerca gains DEA licence; ISO 9001 certification

Ricerca Biosciences has gained a US Drug Enforcement Agency (DEA) licence for its Concord, OH, facility which allows the company to produce controlled bulk APIs for phase I to II trials. Additionally, Ricerca's Lyon facility has obtained the ISO 9001:2008 certification. The company's Taipei facility received the ISO 9001:2008 certification in October 2009.
Outsourcing Pharma
Ricerca

AMRI to buy back $10m shares

Business Week

Monday, 21 June 2010

UKTI seeks companies for UK pavilion at CPhI

UK Trade & Investment is seeking UK-based companies offering UK-origin products and services within the fine and speciality chemical industry, as well as relevant service providers to the pharmaceutical industry for the UK pavilion at CPhI in October.
For more information contact UKTI

Siegfried has broken ground on its new 700m2, $1.5m warehouse in Pennsville, NJ

NJ.com

Kaneka has acquired biologics manufacturer, Eurogentec

Nikkei

Codexis and Merck receive Presidential award

Merck and Codexis have been awarded the Presidential Green Chemistry Challenge Award from the US Environmental Protection Agency for their development of a novel biocatalytic method for the synthesis of diabetes drug, sitagliptin. The award recognises new technologies that help prevent pollution by reducing or eliminating hazardous waste in industrial production. Additionally, the companies have published details of the process, which uses a customised enzyme to perform a key step in the synthesis, in the journal Science.
Codexis
Reuters

FDA plans new manufacturing rules

The US FDA is planning to new regulations to tighten up regulations for drugmakers that outsource manufacturing. The FDA said it may require drugmakers to conduct on-site audits of contract manufacturing facilities. Additionally, the agency is considering issuing warning letters to both the contact manufacturer and drugmaker if issues are found.
Wall Street Journal

Thursday, 17 June 2010

AMRI has acquired Hyaluron for $27m to add pre-filled syringe contract manufacturing capabilities

Reuters

Evonik has commissioned its precious-metal powder catalysts manufacturing plant in Shanghai

Evonik

Jubilant invests in Gujarat

Jubilant Organosys is building two 10,000-tonne/year units at its special economic zone at Bharuch in Gujarat. One plant will produce niacinamide and the other 3-cyanopyridine.
Business Standard

SAFC invests in Scotland and Missouri facilities

Sigma-Aldrich's SAFC division is expanding its network of global 'Centers of Excellence' designed specifically to support the seamless upstream and downstream production of liquid cell culture reagents at its St. Louis, Missouri site and its Irvine, Scotland facility. The work is expected to finish in Q4 2010.
SAFC

Rumour: Is Lilly looking to add custom manufacturing facilities in India?

DNA India

Synthetech reported a 37% decline in revenues in its Q4 ended 31 March to $4.2m and a decline of 23% to $15.2m for its fiscal 2010

Synthetech

Thursday, 10 June 2010

Lonza adds development services

Lonza has launched a new set of immunogenicity, stability and protein engineering services designed to improve the quality, safety, efficacy and manufacturability of antibodies, therapeutic proteins and vaccines. The Applied Protein Services platform complements the company's process development and manufacturing capabilities while advancing its efforts to incorporate Quality by Design (QbD) principles.
Lonza

Xcellerex building biomanufacturing facility

Xcellerex has started construction of its state-of-the-art cGMP biomanufacturing facility in Marlborough, MA. The facility will use Xcellerex's single use bioreactors and downstream unit operations to provide bridge biomanufacturing services for clients that are planning or building their own facilities using Xcellerex technology. The plant, which is due to be completed in September, will also support Xcellerex’s contract manufacturing operations.
Xcellerex

DSM BioSolutions will manufacture Novacta Biosystems' C. difficile antibiotic compound at its Capua, Italy, facility

Manufacturing Chemist

Tuesday, 8 June 2010

Cellectis bioresearch will use its meganuclease technology to deactivate the glutamine synthetase in Lonza’s proprietary CHO cell line

Cellectis

Albemare to build kilo-lab in Belgium

Albemarle fine chemistry services division is building a state of the art kilo lab in Louvain la Neuve, Belgium. The facility will contain the highest quality processes and safety features and have capabilities up to and including 50L glass lined vessels.
Albemarle

Ash Stevens to expand capacity

Ash Stevens will invest $20m to expand its API production capabilities in Riverview, MI, over the next five years. CEO Stephen Munk believes this will expand production by 50-80% and allow the company to hire another 50 workers. In the first phase Ash Stevens will add a 1000m3, $3.5m warehouse, which will be completed by October. The second phase of the project, which will start in 2011, will replace a 3400L reactor bay with a 8500L reactor bay with 1900L, 2800L-gallon and 3800L vessels.
Crain's Detroit

Lonza will manufacture and market California Stem Cell's pluripotent stem cell products

Nasdaq

Almac is planning to add 260 jobs at its new headquarters building near Philadelphia

Philadelphia Business Journal

Fine chems sales grow for Johnson Matthey

Sales at Johnson Matthey's Fine Chemicals Division rose 2% to £219m and operating profit rose 13% to £55.8m. The company expects to deliver steady growth in the divison, but said that H1 results this year would be impacted by the absence of the $12m one-off benefit in 2009/10 from the launch of the generic version of Adderall XR.
Johnson Matthey

Angel Biotechnology reported a reduced Q1 loss and expects to make its first profit in H1

The Herald

Ubichem research has received approval to supply radiolabelled APIs

Out-sourcing Pharma

Angel Biotechnology will provide GMP manufacturing to Materia Medica for antibodies, in a £1.3m contract

Angel Bio

Siegfried will supply at least 60% of Jazz Pharmaceuticals sodium oxybate requirements

Siegfried

Sales at Dottikon fell 25% to CHF113.1m in the year to 31 March

Dottikon